OPTOMIC ESPAÑA S.A
ES-MF-000003235 · Spain · COLMENAR VIEJO (MADRID)
OPTOMIC ESPAÑA S.A is registered in the European database on medical devices as a manufacturer, with 92 devices declared. It has a similarly named entry in the FDA register that we have not verified.
What this manufacturer declares
| Class IIa | 92 |
|---|
Among these devices, 59 are declared active.
Devices declared under this manufacturer
- OCULA
- OP-HL22D LED
- OP-HL7 LED
- OP-MH ERGO FootRest
- OP-MH+ STANDARD FootRest
- OP-MV22 MD FULL HD
- OPT Ø10mm x 158mm x 90º AUT.
- OPT Ø2,7mm x 140mm x 30º AUT.
- OPT Ø2,7mm x 75mm x 30º AUT.
- OPT Ø4mm x 185mm x 30º AUT.
- OPT Ø4mm x 50mm x 0º
- OPT Ø4mm x185mm x 45º AUT.
Showing 12 of 92 declared devices.
Catalogue references include 28503843, 30573666, 38533887, 38613364, 38613846, 38613860.
European nomenclature codes declared: V08020101, Z12021008, Z12011101, Z121402, Z12021007, Z129004.
United States market access
| FDA establishment register | Similar name found — unverified |
|---|---|
| Matched entry | OPTOMIC ESPANA, S.A. (ES) · FDA 9617248 |
| Devices in EUDAMED | 92 |
| Country of registration | Spain |
⚠️ A similar name exists; we do not assert it is the same company — why.
Device-level evidence
| Devices with a numeric GTIN | 92 |
|---|---|
| Found in the U.S. device database | 47 |
| Share | 51.1 % |
Canadian market access
| Health Canada licence listing | Not found in the Canadian register |
|---|
⚠️ Canada lists no Class I devices at all — what that excludes.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
G10 034400 0017 | issued | 2029-08-01 |